PHARMACEUTICAL PRODUCTS CONSULTING
Global Regulatory Partners, LLC (GRP) works with pharmaceutical companies around the globe to meet regulatory, quality and clinical standards. Whether you are launching a new product or re-purposing an existing drug for a new therapeutic use, we know what it takes to clear the regulatory hurdles and get to market.The regulatory professionals at GRP have full life-cycle process knowledge at strategic and tactical levels.
We can guide you through the various steps in the regulatory process for pharmaceuticals, including:
- NDA submission (New drug application)
- CTD submission (Common Technical Document)
- Post market surveillance requirements
With world-wide field experience, GRP’s team navigates companies through the complex and continuously changing regulatory processes worldwide. Our specific experience includes:
- US FDA requirements
- CFDA (China Food and Drug Administration) requirements
- Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
- Brazilian Health Surveillance Agency (ANVISA)
- European Union pharmaceutical regulations including Certificates of Suitability (CEP)
Also, as U.S. based company, GRP can serve in the role of an authorized representative for foreign companies looking to market their products in the U.S. as well as U.S. companies looking to expand overseas.
For many pharmaceutical companies, GRP serves as an extension of the internal regulatory compliance team. We understand that your organization works fervently to ensure the quality of your product. We work with this same passion to ensure that your product gets to market as quickly as possible.
Biologics, while similar to pharmaceuticals in some ways, have unique regulatory requirements. When you need a clear pathway to regulatory approval, turn to GRP. We can assess your needs, develop product approval pathways, support clinical studies, and interface with health authorities to achieve regulatory approval. Our team members provide expert insight and clarity to the regulatory approval process. GRP can determine which regulatory requirements apply to you and provide high-quality submission preparation to accelerate the approval process. We have experience with biologics-specific requirements, including:
- BLA (Biologics License Application)
- IND submissions (Investigational New Drug Application)
- NDA submissions (New Drug Application)